News Briefs: TG Therapeutics Withdraws Pending Applications for Ublituximab/Ukoniq Combo

TG Therapeutics, Inc. said April 15 that it voluntarily withdrew its pending Biologics License Application (BLA)/supplemental New Drug Application (sNDA) for the combination of ublituximab and Ukoniq (umbralisib) for the treatment of adults with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma. The company said it made the decision based on updated overall survival data from the UNITY-CLL Phase III trial. The company also said that it voluntarily withdrew Ukoniq from sale for two indications: (1) for adults with marginal zone lymphoma who have received at least one anti-CD20-based regimen, and (2) for adults with follicular lymphoma who have received at least three prior systemic therapies. The FDA gave the drug accelerated approval for those indications on Feb. 5, 2021. On Feb. 3, 2022, the company disclosed that the FDA was investigating a possible increased risk of death with Ukoniq based on initial findings from the UNITY clinical trial. The FDA had scheduled an April 22 meeting to discuss the sNDA for the combination therapy, as well as Ukoniq’s accelerated approvals. Following TG Therapeutics’ withdrawal of the BLA/sNDA and Ukoniq’s existing indications, the agency cancelled the meeting. The FDA is expected to make a decision on the BLA for ublituximab in relapsing forms of multiple sclerosis by Sept. 28, 2022.

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